Quality and Safety Compliance Supervisor

Summary

Supervises ARKRAY Miami facilities for the development, management, and continued improvement of OSHA-regulated safety initiatives and FDA-regulated quality systems.

Duties and Responsibilities

• Manage ARKRAYs customer returns and complaint activities, including investigations and international shipments. Maintain Quality System processes, procedures and records ensuring compliance to FDA and ISO requirements specific to these processes.
• Facilitate, manage and maintain safety compliance to OSHA standards and regulations
  • Help establish written policies and work procedures that will create and maintain a safe workplace (OSHA)
  • Ensure employees are properly trained on health and safety practices and regulatory standards (OSHA)
  • Complete safety orientation with new hires to show the locations of safety equipment, evacuation routes, external meeting points, and potential hazards.
• Responsible for preventative maintenance and calibration program, general upkeep of facilities, equipment monitoring, waste removal (e-waste, Biohazard and Chemical) and recycling.
  • Maintain tracking maintenance/calibration schedules, and spare parts inventories as applicable.
• Supervise resources and daily work operations related to ARKRAYs product returns, complaint investigations and calibration/maintenance activities to meet department objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching counseling and disciplining employees; communicating job expectations, planning monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.

• Responsible for writing, reviewing, and maintaining procedures per ISO 13485 and 21 CFR part 820 requirements.
• Participate in Safety Committee meetings and help facilitate action items as applicable.
• Other duties as required, including the management of audits and site visits by OSHA state, county, and city officials.

Knowledge and Skills

• Knowledge of FDA, ISO, OSHA and medical industry regulatory requirements is preferred.
• 3 years related quality assurance, quality system experience or an equivalent combination of experience and education. Medical device experience preferred.
• Supervisory experience is required.
• Ability to process technical information using sound judgment and providing clear rationale when making decisions
• Proficient in use of Microsoft Office
• Good organizational, attention to detail and follow-through skills
• Excellent verbal communication and customer interface skills

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities.

Medical, Dental, Vision, 401K with company match, HSA and FSA options